Post on 31-Mar-2015
transcript
Advances in Intraocular lenses
Answers for Presbyopia
Jim Simms, VP Refractive Products, Lenstec
Why Recommendan IOL for Presbyopia?
ALL Clear VisionALL Clear Vision™™Near, Far and in-between
You can help your patients with a new
answer …
The Tetraflex™
Freedom from Spectacles
Cataract and High Refractive Presbyopic Patients Juggle Spectacles
Why We Need Reading Glasses and Develop Cataracts
The changes to our eyes usually follow a
predictable course …
• Presbyopia develops in the 40s
• Cataract formation is noticeable in the 60s
Our Eyes ChangeAs We Age
The eye becomes lessefficient and can no longer make delicate adjustmentsand we lose the ability toaccommodate.
As we age we will notice ourvision appears dim or blurry,and colors are not as brightor crisp.
As our eye ages we may notice increased headlight glare when driving at night.
What Are Cataracts?
• Progressive condition: natural lens becomes cloudy and eventually opaque
• Most common cause is the aging process
• By the age of 60 half the population develops the early stages of cataract
• Almost everyone over the age of 70 will show some degree of cataract formation
• Develop slowly in most people, gradual deterioration in vision becomes more noticeable over time
Symptoms• Cloudy, fuzzy, or filmy vision• Changes in the way we see colors• Headlights seem too bright when driving at night• Glare from lamps or the sun• Double vision
What Is Presbyopia?
The inability of the eye to focus sharply on nearby objects
What is The Tetraflex™ and How Can it Help Your Patients?
The natural lens is removed frominside the eye and an IOL is putin its place.
Lens surgery is a commonsurgical procedure performedon millions of patients annually Worldwide to treat cataracts
More patients and their doctorsare choosing Presbyopic IOL’s forRefractive corrections as analternative to LASIK
The Tetraflex™
Replacing the natural lens, and allows restoration of near, far, and intermediate vision after cataract surgery, and as an alternative for some
patients considering refractive surgery (LASIK)
Near Close Far
ALL Clear VisionALL Clear Vision™™
Freedom from glasses for 95% of daily activitiesFreedom from glasses for 95% of daily activities
Intermediate
Presbyopic Market Potential The Aging Eye
Presbyopia is characterized by progressive age related loss of accommodative
amplitude
• Begins early in life and culminates in a complete loss of accommodation by about 50 years of age.
• Most prevalent of all ocular afflictions eventually affects 100% of the population.
• Generally results in a need for a near spectacle correction or near addition lenses such as bifocal reading glasses.
Presbyopia:presby (old) + opia (vision)
AgeAMP of ACCOM
AgeAMP of ACCOM
10 11.00 35 6.5
15 10.25 40 5.50
20 9.50 45 3.5
25 8.50 60 1.25
30 7.50 70 1.00
AgeAmplitude less than 5 D
Myopes Hyperopes
38 0% 17%
40 23% 67%
42 57% 70%
44 75% 92%
45 82% 100%
•Point where clear or comfortable vision at the desired nearpoint is not obtainable
•Amplitude of accommodation is less than 5 D
•Age of onset is variable, but the majority of patients will need near correction by age 45.
Presbyopic IOL2 Patient Segments
• Traditional cataract patients who want more than mono-vision from cataract surgery
• Refractive lens exchange patients who are too old for LASIK but too young for traditional cataract surgery
Presbyopic IOLCataract Patient Lifestyle Profile
• Won’t settle for less• Works hard to take advantage of
today’s technological advancements: flat-screen plasma TV, home entertainment centers, satellite radio, high speed internet
• Do not settle for the “norm”; want advancements to reading glasses.
• Highest earning years• Not a question of being able to afford
the cost, but rather the perceived value is equal or greater than the fee
• If properly informed about the potential benefits of Presbyopic IOL’s, these consumers will want them.
Presbyopic IOLRefractive Lens Exchange Patient Profile
• Middle aged segment of today’s population• Too old for LASIK and too young for cataract
surgery• Looking for a superior alternative to reading
glasses or bifocals• Want to maintain a higher quality of vision
throughout their life, despite their age or refractive error
• This group has impressive outcomes• Need more than correction for presbyopia:
myopia, hyperopia, or astigmatism.• Have reduced vision due to compromised
contrast sensitivity.
Quality of vision is greatly improvedwith refractive lens exchange
SURGICAL OPTIONS FOR
PRESBYOPIA
•Accommodative intraocular lens
•Multi-focal intraocular lens
•Scleral expansion procedures
•Multi-focal Lasik
•Radio Frequency
•Corneal Inlays
Cataract Patients (Premium) & Refractive Surgery
Optometry Response to Presbyopic Treatment
OptionsSource: Review of Optometry
Which of the following surgical modalities do you believe holds the most promise for treating presbyopia?
A. Multifocal laser ablations 5% B. Scleral expansion surgery 8%C. Multifocal IOLs 32%D. Accommodating IOLs 50%E. Corneal inlays 0%
Why chooseRefractive Lens Surgery?
An IOL offers significant advantages over othertypes of refractive surgery
• Removal of the natural lens means a cataract will not develop as patient becomes older
• Magnification is at the natural level • Full peripheral (side to side) vision • Astigmatism can be addressed • Minimal risk of glare and halos • Permanent or replaceable solution to freedom from
spectacles
The next generation of IOL, designed tomimic the NaturalLens.
THE COMBINEDEffect:
The Tetraflex™
Live... with less dependence on glasses...
•Liner forward and Back Movement•Varies by individual - analogy of a handshake•Aggressive readers •Radius of curvature changes•Subjective abberometor/TRACEY
The Tetraflex™ Promise
The Tetraflex lens is designed to permanently provide excellent distance and intermediate vision along with useful reading vision. Activated by the natural accommodation process of the eye, the lens optimizes the optic for near, intermediate and far vision.
NearNear CloseClose
FarFar
ALL Clear VisionALL Clear Vision™™
IntermediateIntermediate
Specifications
• Optic Size: 5.75mm• Optic Type: Equiconvex• Length: 11.50mm• Haptic Style: Tetraflex• Angulation: 5 Degrees• Construction: 1 Piece• Positioning Holes: 0• Optic Material: Acrylic (26% Water Content)• A Constant: 118.0• A/C Depth: 5.10• Diopter Increments: Whole: +30.0 to +36.0 Half: +5.0 to +18.0
+25.0 to +30.0 0.2: +18.0 to
+25.0
• Simple-to-use lens• Injectable via a 1.6mm cartridge • No variation in surgeons standard phaco technique• Minimal learning curve• Does not to require patients adopation of unnatural multi-focal duality
Michal Janek, MD
PLZEN, Czech Republic
“Accommodative Amplitude demonstrate 90% gain 2 to 3 dioptres of accommodation
and 50% achieved more than 3D”
3.58 3.48 3.46
0
0.5
1
1.5
2
2.5
3
3.5
4
month 1 month 3 month 6
AA (D)
Amplitude of Accommodation-Binocular
2-10
1.75-5.5 2-8
*
Source: Deepak Chitkara
FDA Data 138 Patients 6 months Postoperative
Distance Corrected Near VisionDistance Corrected Near Vision
26
127
19
38
24
39
56 56
69
88
0
20
40
60
80
100
20/20 or better 20/25 or better 20/30 or better 20/40 or better
1 Month 3 Month 6 Month
%%
Uncorrected Distance VisionUncorrected Distance Vision
62
70 69
86 8694 95 92 94 95 95
100
0
20
40
60
80
100
20/20 or better 20/25 or better 20/30 or better 20/40 or better
1 Month 3 Month 6 Month
%%
Understanding Natural Accommodation
The lens increases in thickness and the anterior chamber shallows.
The ciliary muscle enlarges and redistributes its massposteriorly.
The Mechanism of Accommodation
The Tetraflex™ Applied Theory of Accommodation
• Two forces are activated during accommodation: vitreous movement and ciliary muscle swelling.
• Both of these forces can move the optic forward and/or backward during accommodation.
• The Tetraflex optic is designed to act as a “sail,” catching the wave of vitreous to provide maximum forward movement for near vision and return to the intended plane in the “flat” position for clear intermediate and distance vision.
Design Applied to Theory
• Designed with a unique anterior angulations, and patented 5˚ contoured haptic
Evaluation Of TheEvaluation Of The Tetraflex Tetraflex Presbyopic Presbyopic Accommodative IOLAccommodative IOL
Using the iTrace AberrometerUsing the iTrace Aberrometer
SOURCE: Donald R. Sanders, M.D., PhD., David C. Brown M.D., Deepak Chitkara, M.B., ChB. D.OSOURCE: Donald R. Sanders, M.D., PhD., David C. Brown M.D., Deepak Chitkara, M.B., ChB. D.O.
Normal Accommodation 3D Refraction Map (Vertical)
DIFFERENCEDIFFERENCE
NEARNEARDISTANCEDISTANCE
Normal Accommodation 3D Refraction Map (Vertical)
DISTANCEDISTANCE
Mean = +0.4DMean = +0.4D
1.2D 1.2D RefractiveRefractive
RangeRange
HyperopiaHyperopia
MyopiaMyopia
Normal Accommodation 3D Refraction Map
DIFFERENCEDIFFERENCE
Mean = -4.75DMean = -4.75D
2.4D Refractive Range2.4D Refractive Range
With Normal Accommodation and Near Focus
- Refraction shifts to More MyopiaRefraction shifts to More Myopia
- Refractive Range IncreasesRefractive Range Increases
Monofocal IOL 3D Refraction Map
DIFFERENCEDIFFERENCE
NEARNEARDISTANCEDISTANCE
Monofocal IOL 3D Refraction Map
DIFFERENCEDIFFERENCE
No Refractive No Refractive DifferenceDifference
0.6D0.6D Refractive Refractive
RangeRange
Tetraflex in Other Eye 3D Refraction Map
DIFFERENCEDIFFERENCE
NEARNEARDISTANCEDISTANCE
Tetraflex in Other Eye 3D Refraction Map
DISTANCEDISTANCE
Mean = +1.6DMean = +1.6D4.1D 4.1D RefractiveRefractive
RangeRange
+2.8D+2.8D
-1.3D-1.3D
Tetraflex in Other Eye 3D Refraction Map
NEARNEAR
Mean = +1.1DMean = +1.1D
8.6D 8.6D Refractive Refractive
RangeRange
+3.8D+3.8D
-4.8D-4.8D
Summary
The Tetraflex Accommodative IOL is associated with a widened refractive range and more myopia with near fixation, which can explain the enhanced near acuity compared to monofocal IOLs.
Global Users Panel ASCRS2005/Washington, D.C Experience with The Tetraflex™
• Sunil Shah: “my father has had cataract surgery and this is the lens we put in. He is 20/25 in either eye, and he’s about Jaeger 2 unaided”
• Deepak Chitkara: “almost 90% 0f patients are getting J3 or better”
• Jorgé Alio: “all of my patients are around J3 or J4 or better”
• Jose Rincon: “I have Jaeger 1 or better 10%; Jaeger 2 or better 20%; Jaeger 3 or better 60%, Jaeger 4 or better, 100%.”
• Carlos Verges: “very nice distance visual acuity; about 20/25; 20/20. And, the near vision acuity is about 20/40, J3/J4 now defined as near social vision acuity”
Performance ComparisonThe Tetraflex vs. Multi-focal
• Deepak Chitkara: “multi-focals have the fundamental issue, that they are an unnatural situation”
• Jorgé Alio: “with mulit-focals some patients are unhappy even with good near and far vision because probably their neuro-processing is not ready for multi-focality in every case”
• Carlos Verges: “with multi-focal lenses we have to balance between the effective near vision and the secondary problems due to halos, compromised visual quality, and other related problems”
Multi-focal
Candidates for refractive cataract surgery have high expectations
Rosa Braga-Mele, MEd, MD, FRCSC; Hawaiian Eye 2006 • “A happy patient is better than achieving an arbitrary Snellen acuity value”• Understanding the patient’s personality is far more important that the medicine.• Patient success : “10% medicine, 90% personality.” Easygoing patients may be
easier to please than those who are demanding and perfection-oriented.• When determining IOL for refractive cataract patients: divide common activities into
zones of vision.• Zone 1 would include the most demanding of up-close activities, such as reading a
drug label or a phone book and sewing. Zone 2 includes reading the newspaper or a menu and using the computer. Zone 3 includes activities such as watching TV, cooking and common household tasks. Zone 4 involves vision used during daylight hours, such as playing golf. Zone 5 includes the most demanding of scotopic vision, such as night driving or dim illumination such as candlelight
• With current technology, can effectively give patients about three continuous zones of vision: zones 1 to 3, zones 2 to 4, or zones 3 to 5.
• Multifocal IOLs tend to work better for zones 1 to 3, accommodating IOLs tend to work better for zones 2 to 4, and aspheric monofocal IOLs tend to work better in zones 3 to 5.
• Understanding which zones are most important to your patient is critical to achieve success with refractive cataract surgery.
GLOBAL VISION ADVANTAGEGLOBAL VISION ADVANTAGE Near, Far and in-between … Clear VisionNear, Far and in-between … Clear Vision
• Carlos Verges: “for me intermediate vision is critical for those people who work with computers, and they have to work with intermediate distance. In this case I think the Tetraflex lens is much better.”
• Jorgé Alio: “Tetraflex provides patients a near vision improvement, excellent far vision and intermediate vision, and no visual disturbance.”
• Sunil Shah: “I feel the Tetraflex is the best presbyopic lens at the moment and I don’t use multi-focal lenses anymore at all.”
Patient Education is KEY
Ensure they have new knowledge:
• Qualities of an ideal candidate• Realistic expectations for most patients• Recovery times• Pain and comfort issues• Possible risk and complications• Understand entire process from workup thru
postoperative recovery
Lenstec support
• Skills/knowledge transfer to surgeon, staff, and referral network.
• Patient education materials: high image brochures, office posters, PowerPoint presentations for patient and referral education, web site with directory of global users (in development) – directing patients to you!
• Professional referral program development: education, high profile speakers at societies, regional symposia
Lets us know how we can help you grow your practice, and better
serve your patients
THANK YOU!